Search
Sharan Murugan
- Apr 4
- 2 min
USFDA: Guidance one eSubmission of Expedited Safety Reports From IND-Exempt BA/BE Studies and Data Integrity for In Vivo BA & BE studies
Today (04 April 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released draft guidance on...
25 views0 comments
Sharan Murugan
- Feb 17
- 1 min
USFDA Guidance: Q&A-Charging for Investigational Drugs Under an IND - What You Need to Know
Earlier this week (14 February, 2024) the the U.S. Food and Drug Administration (FDA) released guidance "Charging for Investigational...
32 views0 comments
Sharan Murugan
- Dec 8, 2022
- 1 min
USFDA Proposal: IND Annual Reports for More Comprehensive, Consistent with International Regulations
Earlier today (08-December-2022), the US Food and Drug Administration proposed a new annual reporting requirement for investigational new...
75 views0 comments
Sharan Murugan
- Nov 1, 2022
- 1 min
USFDA Guidance: Expanded Access to IND Q&A and Assessing User Fees under OMUFA
Earlier Today (1-November-2022), the U.S. Food and Drug Administration issued a revised draft guidance for the industry, “Expanded Access...
33 views0 comments
Sharan Murugan
- Aug 22, 2022
- 1 min
USFDA Guidance: Charging for Investigational Drugs Under an IND: Questions and Answers
This draft guidance is released today for Public comments and when finalized, this guidance will replace Charging for Investigational...
11 views0 comments
Sharan Murugan
- Apr 17, 2022
- 2 min
FDA's Bioavailability Guidance for NDAs or INDs- General consideration
The US Food and Drug Administration (FDA) has published a final guidance regarding bioavailability data that drug sponsors should include...
26 views0 comments